MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X SURFACELINK MODULE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SRFLNK-I-01

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

During a redo premature ventricular contraction procedure, the surface electrodes could not be validated resulting in a procedure delay.The electrodes could not be validated due to a surface electrode impedance error that occurred within 10 seconds of connecting the system reference electrode.The patient reference electrode was replaced while waiting for the replacement surface link to arrive but did not resolve the issue.A replacement module from another hospital was used to complete the procedure causing a 45 minute / hour delay.

Manufacturer Narrative

Additional information: d9, g3, h2, h3 one ensitex surfacelink (surflink) module was received for evaluation.Visual inspection revealed the exterior casing, labels, and electrical pins were free of physical damage.The cable insulation was intact, and the connector was free of physical damage.The module was recognized upon connecting to a test station.Evaluation testing revealed that the surflink primary active patch did not produce an expected signal.The voltage readings measured at the (right leg or neutral) ecg electrical pin verified the electrical pin was non-functional.Internal inspection revealed that the connection to the primary pin of the belly patch was loose or not connected causing an electrical open (non-functionality).The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances associated with the reported event were identified.The reported symptom was duplicated by signal observation and internal inspection.Based on the investigation and information provided to abbott, the reported event was confirmed, and the root cause was attributed to an electrical open to the active belly patch pin from an undetermined event.

• Brand Name: ENSITE¿ X SURFACELINK MODULE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18283657
• MDR Text Key: 329950458
• Report Number: 2184149-2023-00239
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SRFLNK-I-01
• Device Lot Number: 782570001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1